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Last Updated: April 1, 2026

South Africa: These 13 Drugs Face Patent Expirations and Generic Entry in 2026 - 2027

DrugPatentWatch® Estimated Loss of Exclusivity Dates in South Africa

Generic Entry Dates in Other Countries

These estimated drug patent expiration dates and generic entry opportunity dates are calculated from analysis of known patents covering drugs. Many factors can influence early or late generic entry. This information is provided as a rough estimate of generic entry potential and should not be used as an independent source. The methodology is described in this blog post.

Summary: South Africa: These 13 Drugs Face Patent Expirations and Generic Entry in 2026 - 2027

Tradename Ingredient Estimated Entry Opportunity Date
PANCREAZE pancrelipase (amylase;lipase;protease) 2027-02-20
ZENPEP pancrelipase (amylase;lipase;protease) 2027-02-20
EMBEDA morphine sulfate; naltrexone hydrochloride 2026-06-19
ESBRIET pirfenidone 2026-09-22
FARYDAK panobinostat lactate 2026-06-12
>Tradename >Ingredient >Estimated Entry Opportunity Date

Details: South Africa: These 13 Drugs Face Patent Expirations and Generic Entry in 2026 - 2027

When can PANCREAZE (pancrelipase (amylase;lipase;protease)) generic drug versions launch?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: February 20, 2027
Generic Entry Controlled by: South Africa Patent 200,905,630

PANCREAZE is a drug marketed by

See drug price trends for PANCREAZE.

The generic ingredient in PANCREAZE is pancrelipase (amylase;lipase;protease). There are six drug master file entries for this API. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can ZENPEP (pancrelipase (amylase;lipase;protease)) generic drug versions launch?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: February 20, 2027
Generic Entry Controlled by: South Africa Patent 200,905,630

ZENPEP is a drug marketed by

See drug price trends for ZENPEP.

The generic ingredient in ZENPEP is pancrelipase (amylase;lipase;protease). There are six drug master file entries for this API. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can EMBEDA (morphine sulfate; naltrexone hydrochloride) generic drug versions launch?

Generic name: morphine sulfate; naltrexone hydrochloride
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 19, 2026
Generic Entry Controlled by: South Africa Patent 200,810,501

EMBEDA is a drug marketed by Alpharma Pharms. There are seven patents protecting this drug and four Paragraph IV challenges.

This drug has seventy-four patent family members in twenty-three countries.

See drug price trends for EMBEDA.

The generic ingredient in EMBEDA is morphine sulfate; naltrexone hydrochloride. There are twenty-three drug master file entries for this API. Additional details are available on the morphine sulfate; naltrexone hydrochloride profile page.

When can ESBRIET (pirfenidone) generic drug versions launch?

Generic name: pirfenidone
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: September 22, 2026
Generic Entry Controlled by: South Africa Patent 200,802,237

ESBRIET is a drug marketed by Legacy Pharma. There are twenty patents protecting this drug and two Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has two hundred and sixty-six patent family members in forty-six countries. There has been litigation on patents covering ESBRIET

See drug price trends for ESBRIET.

The generic ingredient in ESBRIET is pirfenidone. There are twenty-three drug master file entries for this API. Twenty-four suppliers are listed for this generic product. Additional details are available on the pirfenidone profile page.

When can FARYDAK (panobinostat lactate) generic drug versions launch?

Generic name: panobinostat lactate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 12, 2026
Generic Entry Controlled by: South Africa Patent 200,809,094

FARYDAK is a drug marketed by Secura. There are two patents protecting this drug.

This drug has sixty-eight patent family members in forty countries. There has been litigation on patents covering FARYDAK

See drug price trends for FARYDAK.

The generic ingredient in FARYDAK is panobinostat lactate. There is one drug master file entry for this API. Additional details are available on the panobinostat lactate profile page.

When can NINLARO (ixazomib citrate) generic drug versions launch?

Generic name: ixazomib citrate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: August 06, 2027
Generic Entry Controlled by: South Africa Patent 201,000,348

NINLARO is a drug marketed by Takeda Pharms Usa. There are seven patents protecting this drug.

This drug has one hundred and eighty-seven patent family members in forty-four countries. There has been litigation on patents covering NINLARO

See drug price trends for NINLARO.

The generic ingredient in NINLARO is ixazomib citrate. One supplier is listed for this generic product. Additional details are available on the ixazomib citrate profile page.

When can VIZAMYL (flutemetamol f-18) generic drug versions launch?

Generic name: flutemetamol f-18
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: August 30, 2027
Generic Entry Controlled by: South Africa Patent 201,000,718

VIZAMYL is a drug marketed by Ge Healthcare. There is one patent protecting this drug.

This drug has twenty-three patent family members in twenty countries.

See drug price trends for VIZAMYL.

The generic ingredient in VIZAMYL is flutemetamol f-18. One supplier is listed for this generic product. Additional details are available on the flutemetamol f-18 profile page.

When can INTRAROSA (prasterone) generic drug versions launch?

Generic name: prasterone
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: August 10, 2027
Generic Entry Controlled by: South Africa Patent 201,000,874

Drug Price Trends for INTRAROSA
INTRAROSA is a drug marketed by Millicent. There are three patents protecting this drug.

This drug has fifty-nine patent family members in thirty-two countries.

See drug price trends for INTRAROSA.

The generic ingredient in INTRAROSA is prasterone. There are seven drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the prasterone profile page.

When can SIGNIFOR LAR (pasireotide pamoate) generic drug versions launch?

Generic name: pasireotide pamoate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: May 24, 2027
Generic Entry Controlled by: South Africa Patent 200,907,168

SIGNIFOR LAR is a drug marketed by Recordati Rare. There are three patents protecting this drug.

See drug price trends for SIGNIFOR LAR.

The generic ingredient in SIGNIFOR LAR is pasireotide pamoate. One supplier is listed for this generic product. Additional details are available on the pasireotide pamoate profile page.

When can KYBELLA (deoxycholic acid) generic drug versions launch?

Generic name: deoxycholic acid
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 19, 2027
Generic Entry Controlled by: South Africa Patent 200,907,928

KYBELLA is a drug marketed by Abbvie. There are fourteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-six patent family members in thirty-eight countries. There has been litigation on patents covering KYBELLA

The generic ingredient in KYBELLA is deoxycholic acid. There are thirty-three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the deoxycholic acid profile page.

When can INVOKAMET XR (canagliflozin; metformin hydrochloride) generic drug versions launch?

Generic name: canagliflozin; metformin hydrochloride
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: December 03, 2027
Generic Entry Controlled by: South Africa Patent 200,903,941

Drug Price Trends for INVOKAMET XR
INVOKAMET XR is a drug marketed by Janssen Pharms. There are three patents protecting this drug.

This drug has two hundred and twenty patent family members in forty-five countries. There has been litigation on patents covering INVOKAMET XR

See drug price trends for INVOKAMET XR.

The generic ingredient in INVOKAMET XR is canagliflozin; metformin hydrochloride. There are twenty-one drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the canagliflozin; metformin hydrochloride profile page.

When can BRILINTA (ticagrelor) generic drug versions launch?

Generic name: ticagrelor
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: August 21, 2026
Generic Entry Controlled by: South Africa Patent 200,900,991

Drug Price Trends for BRILINTA
BRILINTA is a drug marketed by Astrazeneca. There are two patents protecting this drug and two Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has sixty-two patent family members in thirty-five countries. There has been litigation on patents covering BRILINTA

See drug price trends for BRILINTA.

The generic ingredient in BRILINTA is ticagrelor. There are twenty-one drug master file entries for this API. Twenty-six suppliers are listed for this generic product. Additional details are available on the ticagrelor profile page.

When can EXFORGE HCT (amlodipine besylate; hydrochlorothiazide; valsartan) generic drug versions launch?

Generic name: amlodipine besylate; hydrochlorothiazide; valsartan
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 27, 2026
Generic Entry Controlled by: South Africa Patent 200,810,053

Drug Price Trends for EXFORGE HCT
EXFORGE HCT is a drug marketed by Novartis. There has been litigation on patents covering EXFORGE HCT

See drug price trends for EXFORGE HCT.

The generic ingredient in EXFORGE HCT is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this API. Five suppliers are listed for this generic product. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

When can GLYXAMBI (empagliflozin; linagliptin) generic drug versions launch?

Generic name: empagliflozin; linagliptin
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: August 16, 2027
Generic Entry Controlled by: South Africa Patent 200,909,105

Drug Price Trends for GLYXAMBI
GLYXAMBI is a drug marketed by Boehringer Ingelheim. There are fifteen patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has five hundred and twenty-one patent family members in forty-five countries. There has been litigation on patents covering GLYXAMBI

See drug price trends for GLYXAMBI.

The generic ingredient in GLYXAMBI is empagliflozin; linagliptin. There are twenty-two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the empagliflozin; linagliptin profile page.

When can INLYTA (axitinib) generic drug versions launch?

Generic name: axitinib
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: April 05, 2027
Generic Entry Controlled by: South Africa Patent 200,906,990

INLYTA is a drug marketed by Pf Prism Cv. There are three patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

This drug has ninety-seven patent family members in thirty countries. There has been litigation on patents covering INLYTA

See drug price trends for INLYTA.

The generic ingredient in INLYTA is axitinib. There are four drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the axitinib profile page.

When can INVOKAMET (canagliflozin; metformin hydrochloride) generic drug versions launch?

Generic name: canagliflozin; metformin hydrochloride
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: December 03, 2027
Generic Entry Controlled by: South Africa Patent 200,903,941

Drug Price Trends for INVOKAMET
INVOKAMET is a drug marketed by Janssen Pharms. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and seventy-one patent family members in forty-eight countries. There has been litigation on patents covering INVOKAMET

See drug price trends for INVOKAMET.

The generic ingredient in INVOKAMET is canagliflozin; metformin hydrochloride. There are twenty-one drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the canagliflozin; metformin hydrochloride profile page.

When can JAKAFI (ruxolitinib phosphate) generic drug versions launch?

Generic name: ruxolitinib phosphate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 13, 2027
Generic Entry Controlled by: South Africa Patent 200,908,826

JAKAFI is a drug marketed by Incyte Corp. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and thirty-six patent family members in forty-six countries. There has been litigation on patents covering JAKAFI

See drug price trends for JAKAFI.

The generic ingredient in JAKAFI is ruxolitinib phosphate. There are two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the ruxolitinib phosphate profile page.

When can JARDIANCE (empagliflozin) generic drug versions launch?

Generic name: empagliflozin
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: August 16, 2027
Generic Entry Controlled by: South Africa Patent 200,909,105

Drug Price Trends for JARDIANCE
JARDIANCE is a drug marketed by Boehringer Ingelheim. There are fifteen patents protecting this drug and one Paragraph IV challenge. Eighteen tentatively approved generics are ready to enter the market.

This drug has four hundred and twenty-four patent family members in forty-six countries. There has been litigation on patents covering JARDIANCE

See drug price trends for JARDIANCE.

The generic ingredient in JARDIANCE is empagliflozin. There are twenty-two drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the empagliflozin profile page.

When can PROMACTA (eltrombopag olamine) generic drug versions launch?

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: May 03, 2027
Generic Entry Controlled by: South Africa Patent 200,907,710

PROMACTA is a drug marketed by Novartis. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-five patent family members in forty-one countries. There has been litigation on patents covering PROMACTA

See drug price trends for PROMACTA.

The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this API. Nine suppliers are listed for this generic product. Additional details are available on the eltrombopag olamine profile page.

When can TRINTELLIX (vortioxetine hydrobromide) generic drug versions launch?

Generic name: vortioxetine hydrobromide
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 15, 2027
Generic Entry Controlled by: South Africa Patent 200,810,017

Drug Price Trends for TRINTELLIX
TRINTELLIX is a drug marketed by Takeda Pharms Usa. There are ten patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has two hundred and seventeen patent family members in forty-two countries. There has been litigation on patents covering TRINTELLIX

See drug price trends for TRINTELLIX.

The generic ingredient in TRINTELLIX is vortioxetine hydrobromide. There are sixteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the vortioxetine hydrobromide profile page.

When can XENLETA (lefamulin acetate) generic drug versions launch?

Generic name: lefamulin acetate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: March 20, 2027
Generic Entry Controlled by: South Africa Patent 200,905,590

XENLETA is a drug marketed by Hong Kong. There are four patents protecting this drug.

This drug has one hundred and twenty patent family members in thirty-six countries. There has been litigation on patents covering XENLETA

See drug price trends for XENLETA.

The generic ingredient in XENLETA is lefamulin acetate. Additional details are available on the lefamulin acetate profile page.

When can TRELSTAR (triptorelin pamoate) generic drug versions launch?

Generic name: triptorelin pamoate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 06, 2027
Generic Entry Controlled by: South Africa Patent 200,907,940

TRELSTAR is a drug marketed by Verity. There is one patent protecting this drug.

This drug has forty-seven patent family members in thirty-two countries.

See drug price trends for TRELSTAR.

The generic ingredient in TRELSTAR is triptorelin pamoate. There are three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the triptorelin pamoate profile page.

When can WINLEVI (clascoterone) generic drug versions launch?

Generic name: clascoterone
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: August 03, 2027
Generic Entry Controlled by: South Africa Patent 201,000,587

Drug Price Trends for WINLEVI
WINLEVI is a drug marketed by Sun Pharm. There are eight patents protecting this drug.

This drug has ninety-three patent family members in twenty-nine countries. There has been litigation on patents covering WINLEVI

See drug price trends for WINLEVI.

The generic ingredient in WINLEVI is clascoterone. One supplier is listed for this generic product. Additional details are available on the clascoterone profile page.

When can WINLEVI (clascoterone) generic drug versions launch?

Generic name: clascoterone
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: August 03, 2027
Generic Entry Controlled by: South Africa Patent 201,100,133

Drug Price Trends for WINLEVI
WINLEVI is a drug marketed by Sun Pharm. There are eight patents protecting this drug.

This drug has ninety-three patent family members in twenty-nine countries. There has been litigation on patents covering WINLEVI

See drug price trends for WINLEVI.

The generic ingredient in WINLEVI is clascoterone. One supplier is listed for this generic product. Additional details are available on the clascoterone profile page.

When can TEPMETKO (tepotinib hydrochloride) generic drug versions launch?

Generic name: tepotinib hydrochloride
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: July 12, 2027
Generic Entry Controlled by: South Africa Patent 201,001,023

TEPMETKO is a drug marketed by Emd Serono Inc. There are eight patents protecting this drug.

This drug has seventy-nine patent family members in thirty-six countries. There has been litigation on patents covering TEPMETKO

See drug price trends for TEPMETKO.

The generic ingredient in TEPMETKO is tepotinib hydrochloride. One supplier is listed for this generic product. Additional details are available on the tepotinib hydrochloride profile page.

When can KORSUVA (difelikefalin acetate) generic drug versions launch?

Generic name: difelikefalin acetate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: November 10, 2026
Generic Entry Controlled by: South Africa Patent 200,903,053

KORSUVA is a drug marketed by Vifor Intl. There are twelve patents protecting this drug.

This drug has fifty-three patent family members in twenty-seven countries. There has been litigation on patents covering KORSUVA

See drug price trends for KORSUVA.

The generic ingredient in KORSUVA is difelikefalin acetate. One supplier is listed for this generic product. Additional details are available on the difelikefalin acetate profile page.

When can KORSUVA (difelikefalin acetate) generic drug versions launch?

Generic name: difelikefalin acetate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: November 10, 2026
Generic Entry Controlled by: South Africa Patent 200,903,054

KORSUVA is a drug marketed by Vifor Intl. There are twelve patents protecting this drug.

This drug has fifty-three patent family members in twenty-seven countries. There has been litigation on patents covering KORSUVA

See drug price trends for KORSUVA.

The generic ingredient in KORSUVA is difelikefalin acetate. One supplier is listed for this generic product. Additional details are available on the difelikefalin acetate profile page.

When can OPZELURA (ruxolitinib phosphate) generic drug versions launch?

Generic name: ruxolitinib phosphate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 13, 2027
Generic Entry Controlled by: South Africa Patent 200,908,826

Drug Price Trends for OPZELURA
OPZELURA is a drug marketed by Incyte Corp. There are nineteen patents protecting this drug.

This drug has three hundred and thirty-seven patent family members in forty-nine countries. There has been litigation on patents covering OPZELURA

See drug price trends for OPZELURA.

The generic ingredient in OPZELURA is ruxolitinib phosphate. There are two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the ruxolitinib phosphate profile page.

When can XERMELO (telotristat etiprate) generic drug versions launch?

Generic name: telotristat etiprate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: December 12, 2026
Generic Entry Controlled by: South Africa Patent 200,903,367

XERMELO is a drug marketed by Tersera. There are five patents protecting this drug.

This drug has seventy patent family members in twenty-nine countries.

See drug price trends for XERMELO.

The generic ingredient in XERMELO is telotristat etiprate. One supplier is listed for this generic product. Additional details are available on the telotristat etiprate profile page.

When can INPEFA (sotagliflozin) generic drug versions launch?

Generic name: sotagliflozin
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: September 27, 2027
Generic Entry Controlled by: South Africa Patent 200,902,231

Drug Price Trends for INPEFA
INPEFA is a drug marketed by Lexicon Pharms Inc. There are three patents protecting this drug.

This drug has eighty-one patent family members in thirty-three countries.

See drug price trends for INPEFA.

The generic ingredient in INPEFA is sotagliflozin. One supplier is listed for this generic product. Additional details are available on the sotagliflozin profile page.

When can OJEMDA (tovorafenib) generic drug versions launch?

Generic name: tovorafenib
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 29, 2027
Generic Entry Controlled by: South Africa Patent 200,909,223

OJEMDA is a drug marketed by Day One Biopharms. There are two patents protecting this drug.

This drug has fifty patent family members in twenty-seven countries.

The generic ingredient in OJEMDA is tovorafenib. One supplier is listed for this generic product. Additional details are available on the tovorafenib profile page.

When can TRIPTODUR KIT (triptorelin pamoate) generic drug versions launch?

Generic name: triptorelin pamoate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 06, 2027
Generic Entry Controlled by: South Africa Patent 200,907,940

TRIPTODUR KIT is a drug marketed by Azurity. There is one patent protecting this drug.

This drug has forty-seven patent family members in thirty-two countries.

The generic ingredient in TRIPTODUR KIT is triptorelin pamoate. There are three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the triptorelin pamoate profile page.

When can INVOKANA (canagliflozin) generic drug versions launch?

Generic name: canagliflozin
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: December 03, 2027
Generic Entry Controlled by: South Africa Patent 200,903,941

Drug Price Trends for INVOKANA
INVOKANA is a drug marketed by Janssen Pharms. There are three patents protecting this drug and one Paragraph IV challenge. Five tentatively approved generics are ready to enter the market.

This drug has two hundred and twenty patent family members in forty-five countries. There has been litigation on patents covering INVOKANA

See drug price trends for INVOKANA.

The generic ingredient in INVOKANA is canagliflozin. There are twenty-one drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the canagliflozin profile page.

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